Breast Pump Guidance from FDA
If you’re giving your baby breast milk, you probably know there can be times when a breast pump can come in handy.
Breast pumps are medical devices regulated by the U.S. Food and Drug Administration. They can be used to maintain or increase a woman’s milk supply, relieve engorged breasts and plugged milk ducts, or pull out flat or inverted nipples so a nursing baby can latch on more easily.
And there are important safety considerations if you use one.
What kinds of breast pumps are available?
Breast pumps include a breast shield that fits over the nipple, a pump that creates a vacuum to express (or pump) milk, and a detachable container for collecting milk.
Pumps can be manual or powered. Powered pumps can use batteries or a cord that plugs into an electrical outlet. Some pumps even have an adapter for use in the car. (Obviously not while you’re driving, however!)
Double pumps extract milk from both breasts at the same time, while single pumps extract milk from one breast. Find food safety tips for babies, including breast milk storage tips, on the FDA’s website at http://www.fda.gov/Food/FoodborneIllnessContaminants/PeopleAtRisk/ucm089629.htm.
The Affordable Care Act requires most insurance plans to cover the cost of a breast pump as part of women’s preventive health services. You can talk to your insurance company about its coverage.
Is it safe to rent or share a breast pump?
Renting or sharing these devices can be dangerous if pumps are not designed for multiple users.
“Consumers should be aware of the hazards of renting or sharing a breast pump that is not designed for multiple users—even with family and friends,” says H. Paige Lewter, an electrical engineer and device reviewer in the FDA’s Obstetrics and Gynecology Devices branch. “Contaminated breast pumps could cause you and your baby to develop an infection.”
“Even if a used device looks really clean, potentially infectious particles may survive in the breast pump and/or its accessories for a surprisingly long time,” adds Michael Cummings, M.D., an FDA obstetrician-gynecologist.
- Manual breast pumps are designed for one user only (single use) and should never be rented or shared for safety reasons.
- Powered breast pumps that are designed for single users should never be rented or shared.
- Sharing a breast pump may violate the manufacturer’s warranty, which means you may not be able to get help from the manufacturer if you have a problem with the pump.
- The FDA does not recognize the term “hospital grade,” so this term doesn’t mean a pump is safe.
The bottom line for sharing breast pumps designed for single users? Don’t do it.
And if you rent or share from an authorized provider (such as a hospital, lactation consultant, or specialty medical supply store), do so only if the pump is designed for multiple users. And do so only if you have your own accessories kit to avoid contamination. The accessories kit typically includes the milk container, breast-shield, and tubing.
“Multiple-user pumps are designed so that the breast milk can never touch the working parts of the pump that are shared,” says Lewter. “The only part of a multiple-user breast pump that you can safely share is the pump itself.”
What kind of breast pump should you buy?
If you purchase a pump, consider your needs. For instance, if you’ll use the pump only at home, one that plugs into the wall may be fine. But if you’ll pump at work or otherwise away from home, you may want to consider a device that’s easy to carry and battery-powered.
- You should never buy a previously used or “pre-owned” pump designed for single users. That’s because these pumps sold secondhand also can expose you and your baby to contamination.
- Buying a used pump may violate the manufacturer’s warranty.
If you’re not sure which pump or accessories to get, talk to a health care professional who has expertise in breastfeeding.
How should you clean a breast pump?
Contamination can happen even to your personal pump if it is not cleaned properly.
“Correct use and cleaning helps protect you and your baby,” says Lewter.
The FDA recommends cleaning and disinfection between uses. You should read the manufacturer’s instructions for specific information on how to keep your pump clean.
In general, steps for cleaning include:
- Rinsing each piece that comes into contact with breast milk in cool water as soon as possible after pumping;
- Washing each piece separately using liquid dishwashing soap and plenty of warm water;
- Rinsing each piece thoroughly with hot water for 10 to 15 seconds; and
- Placing the pieces on a clean paper towel or in a clean drying rack and allowing them to air dry.
“Wiping the pump body with ethanol or isopropyl alcohol at 70 to 90 percent concentration—or boiling the breast pump parts in water—generally is also acceptable,” Lewter notes. “If the tubing looks moldy or cloudy, stop use and replace the tubing immediately.”
If you’re renting or buying a multiple-user device, ask the person providing the pump to make sure all components (including internal tubing), have been cleaned and disinfected according to the manufacturer’s instructions.
How can you report problems with these devices?
If a breast pump is not working as it should—for instance, if there are electrical problems or issues with suction—you can contact the manufacturer for recommendations on what to do with your device.
If you’re injured while using a breast pump or have pain, contact your health care provider. The FDA also encourages you to report injuries or problems with regulated devices to the agency. You can file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home).
Ms. Jensen is a leading advocate for families and children and was the founder and president of ACES, The Association for Children for Enforcement of Support.
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